Recall of Infinion 1.5 T MRI Scanner.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems (Cleveland) Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
  • Event ID
  • Event Risk Class
    Class 3
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, Nuclear Magnetic Resonance Imaging - Product Code LNH
  • Reason
    There is a potential for the patient to be exposed to cryogenic fluids (liquid air) dripping from the vent during a quench due to the location of the vent.
  • Action
    A Mandatory Service Letter, dated April 17, 2003, was sent to service technicians instructing the technicans to perform a mandatory safety modification.


  • Model / Serial
    Serial Numbers ZA101-ZA188, ZA190-192, ZA195, ZA200, ZA201.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Throughout the United States and to Denmark, England, China, Italy, Mexico, Israel, and Puerto Rico.
  • Product Description
    Intinion 1.5 T MRI Scanner.
  • Manufacturer


  • Manufacturer Address
    Philips Medical Systems (Cleveland) Inc, 595 Miner Road, Cleveland OH 44143-2131
  • Source